от компании (организации): AbbVie в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Клинические исследования"
с заработной платой: по договоренности
Вакансия № 9030505 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Среда, 14 августа 2024 года.
Дата обновления вакансии № 9030505 на сайте Работа в Москве и Московской области (МО, Подмосковье): Вторник, 24 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 9030505 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
1–3 года
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Clinical Research Associate
Main responsibilities:
- Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research;
- Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes;
- Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. proactively manages the site and ensures action plans are put into place as needed to ensure compliance. Ensures regulatory inspection readiness at assigned clinical sites;
- Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel;
- Ensures safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations;
- Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members;
- Manages investigator payments as per executed contract obligations. Negotiates investigator/ hospital agreements with stakeholders. Maintain and complete own expense reports as per local and applicable guidelines;
- Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
Requirements:
- University degree in medicine, pharmacy, nursing or biological science;
- Previous experience in clinical trials (from 2 years);
- Strong organizational, communication and teamwork skills, time management, customer service and interpersonal skills;
- Computer literacy (good knowledge of Word, Excel and Power Point);
- Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials;
- Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations;
- Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Ability to work, understand and follow work processes within the assigned function;
- Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated. Ability to use functional expertise and exercise good judgment;
- Demonstrated business ethics and integrity;
- Russian, English - upper-intermediate.
Откликнуться на эту вакансию: Clinical Research Associate
Предыдущая вакансия:
Вакансия № 9030496 на должность Специалист по подбору персонала от компании ИП Милованова Екатерина Валерьевна в городе (населенном пункте) Москва